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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K921851
Device Name 4 SURE TM SUCTION CATHETERS & KITS
Applicant
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Applicant Contact RANDALL GREEN
Correspondent
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Correspondent Contact RANDALL GREEN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received04/17/1992
Decision Date 07/07/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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